A Study to Investigate the Impact of a Multiple Micronutrient (MMN) Beverage Powder on Vaccine Response in School Children

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status

Withdrawn

Conditions

Growth and Development

Treatments

Dietary Supplement: Control
Dietary Supplement: Test Product

Study type

Interventional

Funder types

Industry

Identifiers

NCT02551627
204476

Details and patient eligibility

About

This will be a double blind, two-arm, parallel-group, stratified for gender, randomised, controlled study in participants aged 7-10 years (yrs). The aim of the study is to test the hypothesis that MMN fortified beverage may help improve immunity outcomes as assessed through vaccine response in 7-10 yrs old school participants.

Sex

All

Ages

7 to 10 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Understanding and willingness to participate in the study as demonstrated by participants' parents and/or Legally acceptable representatives (LARs) voluntary written informed consent, participants' written assent
  • Participants aged between 7-10 yrs, inclusive
  • Good general and mental health
  • Participants with Z-scores of BMI for age of ≥-3 to ≤+1

Exclusion criteria

  • Children in Care (CiC)
  • Known or suspected intolerance or hypersensitivity to the study material or any of their stated ingredients or any known food allergies like peanut allergy, gluten allergy or lactose intolerance
  • Participant who has already been administered cholera vaccine in any form prior to this study and any known contra-indication to oral cholera vaccine
  • Participant who consumed any antibiotics during the week prior to the first dose of study vaccination until the end of the study
  • Severe anemia (Hb < 8 g/dL), recent history (2 months) of serious infections, injuries and/or surgeries
  • Participant consuming nutritional supplement and/or health food drinks on regular basis (≥ 3 times a week) in last 3 months
  • Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder
  • Participants likely to move out of geographical range of the study within study duration
  • Child of an employee of the sponsor or the study site or members of their immediate family, sibling of participant already enrolled in the study
  • Previous participation in this study, in another clinical study or receipt of an investigational drug within 30 days of screening visit; participation in any nutritional study or didactic nutritional education in last 6 months of the screening visit

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups

Test Product
Experimental group
Description:
MMN fortified beverage powder [27 gram (g)] made up in 150 milliliter (mL) of water, will be administered orally as a single serve, twice daily for 18 weeks.
Treatment:
Dietary Supplement: Test Product
Control
Active Comparator group
Description:
Isocaloric beverage powder without micronutrient fortification (27 g), made up in 150 mL of water will be administered orally as a single serve, twice daily for 18 weeks.
Treatment:
Dietary Supplement: Control

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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